| | Class 1 Device Recall Medline General Surgery Tray |  |
| Date Initiated by Firm | December 31, 2024 |
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| Date Posted | January 29, 2025 |
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| Recall Status1 |
Open3, Classified |
| Recall Number | Z-0991-2025 |
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| Recall Event ID |
96093 |
| 510(K)Number | K213481 |
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| Product Classification |
General surgery tray - Product Code LRO
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| Product | Medline General Surgery Tray Kits:
1) ARTERIAL LINE INSERTION KIT, Item Number ART1185B;
2) ARTERIAL LINE BUNDLE, Item Number ART255;
3) ARTERIAL LINE TRAY, Item Number ART350;
4) ARTERIAL LINE BUNDLE, Item Number ART355;
5) ARTERIAL LINE BUNDLE, Item Number ART355 ;
6) ARTERIAL LINE INSERTION TRAY, Item Number ART475;
7) ARTERIAL LINE BUNDLE - OR, Item Number ART535A;
8) ARTERIAL LINE TRAY, Item Number ART545A;
9) ARTERIAL LINE INSERTION KIT, Item Number ART775C;
10) ARTERIAL LINE TRAY, Item Number ART840;
11) ARTERIAL LINE KIT, Item Number ART890B |
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| Code Information |
1) ART1185B UDI-DI: 10653160379225(each), 00653160379228(case), Lot Number: 2024102590;
2) ART255 UDI-DI: 10653160367598(each), 00653160367591(case), Lot Number: 2024082690;
3) ART255 UDI-DI: 10653160367598(each), 00653160367591(case), Lot Number: 2024101590;
4) ART350 UDI-DI: 10653160362050(each), 00653160362053(case), Lot Number: 2024093090;
5) ART355 UDI-DI: 10653160361817(each), 00653160361810(case), Lot Number: 2024081290;
6) ART355 UDI-DI: 10653160361817(each), 00653160361810(case), Lot Number: 2024112590;
7) ART475 UDI-DI: 10653160367659(each), 00653160367652(case), Lot Number: 2024100790;
8) ART475 UDI-DI: 10653160367659(each), 00653160367652(case), Lot Number: 2024073090;
9) ART475 UDI-DI: 10653160367659(each), 00653160367652(case), Lot Number: 2024081590;
10) ART475 UDI-DI: 10653160367659(each), 00653160367652(case), Lot Number: 2024090990;
11) ART535A UDI-DI: 10653160367604(each), 00653160367607(case), Lot Number: 2024100890;
12) ART535A UDI-DI: 10653160367604(each), 00653160367607(case), Lot Number: 2024080190;
13) ART545A UDI-DI: 10653160375135(each), 00653160375138(case), Lot Number: 2024102890;
14) ART775C UDI-DI: 10653160366102(each), 00653160366105(case), Lot Number: 2024083090;
15) ART840 UDI-DI: 10653160366966(each), 00653160366969(case), Lot Number: 2024082390;
16) ART840 UDI-DI: 10653160366966(each), 00653160366969(case), Lot Number: 2024093090;
17) ART890B UDI-DI: 10653160360834(each), 00653160360837(case), Lot Number: 2024100990;
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Recalling Firm/
Manufacturer |
MEDLINE INDUSTRIES, LP - Northfield
3 Lakes Dr
Northfield IL 60093-2753
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| For Additional Information Contact | Haley Barclay
866-359-1704 |
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Manufacturer Reason
for Recall | The catheter subassembly in the Integrated Arterial Catheter was manufactured with excess material on the catheter hub. |
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FDA Determined
Cause 2 | Process design |
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| Action | A MEDICAL DEVICE RECALL notification letter dated 12/31/24 was sent to customers.
REQUIRED ACTION:
1. Immediately check your stock for the affected item number and the affected lot numbers which can be located within the recall portal. Quarantine all affected product immediately.
2. Please use the link and the information below to complete your response form. Please list the quantity of affected product you have in inventory on the form. Even if you do not have any affected product in inventory, please complete and submit the response form.
3. Upon receipt of your submitted response form, your account will receive over-labels to place on affected inventory, with instructions for your staff to remove the affected component prior to using the kit. These labels will be provided via FedEx overnight, if applicable.
The login for completing the response form is:
Website link: https://recalls.medline.com
Recall Reference #: R-24-278-FGX1
Recall Code: RECALL CODE
4. If you are a distributor, or have resold or transferred this product to another company or individual, you are required by FDA regulations to notify them of this recall communication.
If you have any questions, contact the Recall Department at 866-359-1704 or recalls@medline.com. |
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| Quantity in Commerce | 942 kits |
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| Distribution | US Nationwide. |
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| Total Product Life Cycle | TPLC Device Report |
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1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
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| 510(K) Database | 510(K)s with Product Code = LRO
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